Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

qHPV Vaccine in Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36.

Placebo in Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36.

EXT1: Placebo in Base Study

Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7.

EXT1: Incomplete qHPV Regimen in Base Study

Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

Participant Flow for 3 periods

Period 1: Base Study Vaccination Period

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

STARTED

2032

2033

0

0

Vaccinated

2025

2030

0

0

COMPLETED

1818

1814

0

0

NOT COMPLETED

214

219

0

0

Randomized Not Vaccinated

7

3

0

0

Adverse Event

2

4

0

0

Lost to Follow-up

111

112

0

0

Protocol Violation

2

3

0

0

Withdrawal by Subject

64

69

0

0

Uncooperative

2

2

0

0

Moved

20

21

0

0

Site Terminated

1

0

0

0

Unspecified

2

2

0

0

Subject Incarcerated

2

2

0

0

HIV positive

1

1

0

0

Period 2: Base Study Follow-up Period

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

STARTED

1822
[1]

1821
[2]

0

0

COMPLETED

1487

1479

0

0

NOT COMPLETED

335

342

0

0

Adverse Event

3

10

0

0

Lost to Follow-up

232

226

0

0

Withdrawal by Subject

53

64

0

0

Moved

41

36

0

0

Unspecified

2

0

0

0

Protocol Violation

1

0

0

0

Uncooperative

3

4

0

0

Subject Incarcerated

0

2

0

0

[1]

4 subjects who did not receive 3 doses of vaccine in base study continued into the Follow-up Period

[2]

7 subjects who did not receive 3 doses of placebo in base study continued into the Follow-up Period

Period 3: Extension 1

qHPV Vaccine in Base Study

Placebo in Base Study

EXT1: Placebo in Base Study

EXT1: Incomplete qHPV Regimen in Base Study

STARTED

0

0

1098
[1]

16
[1]

COMPLETED

0

0

1041

15

NOT COMPLETED

0

0

57

1

Adverse Event

0

0

2

0

Lost to Follow-up

0

0

35

0

Withdrawal by Subject

0

0

13

1

Other Reason

0

0

4

0

Moved

0

0

3

0

[1]

Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

qHPV Vaccine

Participants who started the base study vaccination period

Placebo

Participants who started the base study vaccination period

Total

Total of all reporting groups

Baseline Measures

qHPV Vaccine

Placebo

Total

Number of Participants
[units: participants]

2032

2033

4065

Age
[units: years]Mean ± Standard Deviation

20.6
± 2.0

20.5
± 2.0

20.5
± 2.0

Age
[1][units: Years]Median ( Full Range )

20
( 16 to 26 )

20
( 15 to 27 )

20
( 15 to 27 )

Gender
[units: participants]

Female

0

0

0

Male

2032

2033

4065

Race/Ethnicity, Customized
[units: participants]

Asian

201

205

406

Black

405

400

805

Hispanic American

412

423

835

Native American

1

2

3

White

719

712

1431

Multi-Racial

291

283

574

Indian (subcontinent)

1

8

9

Polynesian

2

0

2

[1]

Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.

Base study: all AEs were collected systematically from Day 1 through Month 36. Extension 1: SAEs were collected systematically from Day 1 through Month 7. Other AEs were not solicited during EXT1.

Additional Description

Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, and MedDRA version 14.1 was used during EXT1.

Although non-serious AEs were not solicited during EXT1, 1 participant voluntarily reported the non-serious AE of viral gastroenteritis (incidence <1%).

Frequency Threshold

Threshold above which other adverse events are reported

1%

Reporting Groups

Description

qHPV Vaccine: Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study.

Placebo: Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study.

qHPV Vaccine: EXT1

Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7. The at-risk population was participants who received ≥ 1 qHPV vaccination in EXT1 and had follow-up data.